Pigmentation Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
A total of 20 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign hand pigmentation who wish to improve their skin appearance.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | April 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility | Inclusion Criteria: - Healthy Female/Male. - Age= 21-70 (Adults). - Fitzpatrick skin phototype = I-V - Congenital or acquired benign pigmentation on hands. - Presence of at least three (3) lesions with similar pigmentation intensity in the treatment area in diameters larger than 2 mm. - Able to read, understand and provide written Informed Consent. - Able and willing to comply with the treatment/follow-up schedule and requirements. - Women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study. Exclusion Criteria: - History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation. - Tanning (artificial or natural) 1 month prior first treatment and during the entire study duration including follow-up. - Excessive underlying vascular conditions (e.g. dense network of capillaries). - Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding. - Prior skin laser, light or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study. - Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment or during the course of the study. - Prior treatment with medium-depth or deeper, chemical peels or dermabrasion in treated area within 3 months of initial treatment or during the course of the study. - Any other surgery in treated area within 9 months of initial treatment or during the course of the study. - Hypersensitive to light exposure or the use of photosensitive medication for which light exposure is contraindicated. - Multiple dysplastic nevi or suspicious pigmentation in area to be treated. - Presence of underlying tattoo in the treatment area. - Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | "Sk;N" Clinic | London |
Lead Sponsor | Collaborator |
---|---|
Focus Medical, LLC |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hands pigmentation change assessed by investigator | Hands pigmentation change assessed by investigator at the 1 month follow up using the 5-point Pigment Improvement Score where score of between 0 and 4 will be assigned (0- No improvement in pigmentation, 1- Trace to mild improvement of some lesions, 2- Moderate response: some lesions lighter, 3- Good response: most lesions much lighter and 4- Excellent response- Most or all lesions much lighter or gone. | 1 month follow up |
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